Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry (Pharmaceuticals, Biologics, Medical Devices, IVDs)

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America [Brazil, Mexico, Argentina]. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, Orphan Drugs and Combination Products in Latin America The primary countries covered will include: Argentina, Brazil and Mexico. The course will cover topics relating to full product life-cycle management and address the structure of the regulatory agencies in Latin America. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

Seminar Agenda

• Glossary of Terms.
• Defining the Opportunity: Overview of Latin America
• Country Facts: Argentina, Brazil, Mexico.
• Latin America's Regulatory Structure for the Life Science Product Industries
• Brazil – ANVISA Structure & Insight to Operations
• Mexico – COFEPRIS Structure & Insight to Operations
• Argentina – ANMAT Structure & Insight to Operations
• Mercosur - Southern Common Market
• Harmonization Efforts
• Beginning Your Company Involvement in Latin America: Examples of Country Requirements.
• Registration / Required Country Licenses.
• Overview of the Rules Governing Medicinal Products & Medical Devices.
• Clinical Trials, GCP: When are they needed?
• GMP Compliance
• Stability Studies: Zonal Unique Requirements
• Marketing Authorization Process & Dossier Requirements: Pharmaceuticals
• CTD Format Transition
• Summary of Product Characteristics
• Package Inserts
• Labeling Requirements
• Amendments / Variations / Renewals
• Marketing Authorization Processes
• Generic Products & Bioequivalence Testing
• Biologics & Biosimilars
• Orphan Drug Special Processes
• Compassionate Use / Special Access
• Medical Device Registrations & Product Licenses
• Device Classifications
• Amendments / Variations
• Device Renewal Applications
• Drug / Device Master File (DMF): Use in Latin America
• Processing Variations on Licensed Products.
• Labeling & Packaging Leaflet Requirements
• Drug / Device Vigilance & Post-Marketing Responsibilities
• Import / Export Procedures
• Patents / Copyrights / Trademarks
• Advertising & Promotion of Products
• How and When to Influence the Regulatory Process.
• The Regulatory Negotiation Process.
• How to Use Regulations / Regulatory Contacts to Your Advantage.
• Conclusions

Who Will Benefit:

This course will be beneficial to:

• Regulatory personnel whose responsibilities require knowledge of Latin America’s regulatory environment.
• Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant.
• QA / QC Personnel
• Global Supply Chain personnel
• Clinical / Pharma & Device personnel
• Manufacturing personnel
• Global Business Development personnel
• Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit.